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Clinical study for CAR-T cell in the treatment of advanced ROR1+ malignancies

Clinical study for CAR-T cell in the treatment of advanced ROR1+ malignancies

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800019780
Enrollment
Unknown
Registered
2018-11-28
Start date
2018-11-28
Completion date
Unknown
Last updated
2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer, ovarian cancer, etc.

Interventions

1:injecting CAR-T IV
2:injecting CAR-T through serous cavity

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years old, male or female; 2. PS score 0-2 points; 3. Patients with non-small cell lung cancer that is metastatic or inoperable and who have been treated with at least second line of prior therapy or declined conventional therapy; 4. Patients with known epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations must have been treated on at least one line of molecularly targeted therapy (e.g., erlotinib, crizotinib) or chemotherapy; 5. Patients with Ovarian cancer that is metastatic or inoperable and who have been treated with at least second line of prior therapy or declined conventional therapy; 6. ROR1 expression in > 20% of the primary tumor or metastasis by immunohistochemistry (IHC); 7. Patients must be off chemotherapy for a minimum of 3 weeks prior to start of treatment; targeted therapies must be stopped at least 3 days prior to start of lymphodepletion; 8. Fertile male and female patients must be willing to use a contraceptive method before, during and for at least two months after the T cell infusion; 9. Ability to understand and provide informed consent.

Exclusion criteria

Exclusion criteria: 1. Known additional malignancy that is progressing or requires active treatment; 2. Hepatitis B or hepatitis C active period, HIV infected; 3. Suffering from coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage and other serious diseases; 4. 2-3 patients with hypertension or poorly controlled hypertension; 5. Have a history of mental illness that is difficult to control; 6. Any other uncontrolled active disease that impedes participation in the trial; 7. Researchers believe that those who should not participate in this study; 8. Long-term use of immunosuppressants after organ transplantation, except for recent or current inhaled glucocorticoid therapy; 9. In the opinion of the investigator, the presence of medical history or mental state history or laboratory abnormalities may increase the risk associated with participating in the study or study drug administration, or may interfere with the interpretation of the results; 10. Unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events occurred 30 days or 30 days prior to enrollment. If you receive anticoagulation therapy, the subject's therapeutic dose must be stable before enrollment; 11. Pregnant or nursing subjects, or during treatment or after treatment plan subject within two months of pregnancy. During the treatment period and at least 2 months after the end of treatment, female subjects of childbearing age are reluctant to receive subjects with high-efficiency contraception (according to institutional standards). Female subjects of childbearing age are required to provide a negative result of a serum or urine pregnancy test within 48 hours prior to treatment; 12. There are active or uncontrolled infections (except for simple urinary tract infections or upper respiratory tract infections) that require systemic therapy 14 days or 14 days prior to enrollment; 13. Subjects who have a disease affecting the signing of a written informed consent or adherence to the study procedure; or subjects who are unwilling or unable to comply with the research requirements.

Design outcomes

Primary

MeasureTime frame
response evaluation of solid tumor;Adverse Events;

Secondary

MeasureTime frame
count of CAR-T;cytokines;

Countries

China

Contacts

Public ContactWang Yongsheng

West China Hospital, Sichuan University

wangy756@163.com+86 028-85422707

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026